Texas Vaccines for Children and Adult Safety Net Provider Manual

Transcription

1 Texas Vaccines for Children and Adult Safety Net Provider Manual 2018 Texas Department of State Health Services Tel: (800) Fax: (512) West 49th Street Austin, TX

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3 Pg. 01 Table of Contents Table of Contents Introduction to the 2018 Provider Manual and the Texas Vaccines for Children (TVFC) Program 9 I. Provider Manual Information 9 II. Public Health Law Establishing the Vaccines for Children (VFC) Program 9 III. Vision and Mission of the DSHS Immunization Unit 10 IV. Goals of the DSHS Immunization Unit 11 V. Goals of the TVFC Program 11 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT _ 13 I. Provider Eligibility Requirements 13 II. Provider Enrollment Requirements 13 A. Specific Terms of Agreement 13 B. Initial Enrollment 15 C. TVFC Enrollment Visit 18 D. TVFC Site Set-up 21 E. Vaccine Accountability 22 F. Provider Identification Number 23 G. Provider Change of Information 24 H. Annual Re-Enrollment 24 I. Deputization of Clinics 25 III. Provider Withdrawal from TVFC 26

4 Pg. 02 Table of Contents IV. Provider Suspension from TVFC 26 V. Provider Termination from TVFC 27 VI. Re-enrollment after Termination 27 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING 29 I. Patient Eligibility Requirements 29 A. TVFC Patient Eligibility Criteria 29 B. Children s Health Insurance Program 30 C. Medicaid as Secondary Insurance 31 D. Nineteen-year Olds 31 II. Patient Eligibility Screening Record 31 CHAPTER 3: VACCINE MANAGEMENT 35 I. Approved Vaccines 35 II. Vaccine Ordering 36 A. Vaccine Choice 36 B. Vaccine Inventory Plan and Maximum Stock Levels 38 C. Increasing and Decreasing Maximum Stock Levels 39 D. Short-Dated Vaccine 40 E. Storage Capacity for Vaccine Orders 41 F. Vaccine Ordering in the Electronic Vaccine Inventory (EVI) System 41 G. Vaccine Ordering for TVFC Providers without Internet Access 45

5 Pg. 03 Table of Contents H. Vaccine Ordering for Newly Enrolled TVFC Providers 45 I. Ordering Influenza Vaccine 46 J. Vaccine Ordering for Mass Vaccination Clinics 48 III. Vaccine Distribution 49 A. Vaccine Distributors 49 B. Receiving Vaccine Orders 49 C. Manufacturer and Distributor Maintenance of the Cold Chain 52 D. Vaccines Received Warm or Questionable 53 E. Vaccines Received in Error 54 IV. Vaccine Loss 55 A. Expired, Spoiled, and Wasted Vaccine 55 B. Procedures for Vaccine Loss 57 C. Negligent Vaccine Loss 60 V. Vaccine Storage and Handling 61 A. Refrigerator and Freezer Requirements 62 B. Data Logger Requirements 70 C. Vaccine Storage Requirements 77 D. Protective Equipment 78 E. Personnel 78 F. Mass Vaccination Clinic Requirements 80 G. Routine and Emergency Storage and Handling Plan 81

6 Pg. 04 Table of Contents H. Vaccine Protection in the Event of an Emergency 84 I. Cold Chain Management and Vaccine Transport 86 VI. Vaccine Transfers 95 VII. Vaccine Borrowing 97 VIII. Reporting Requirements 99 A. Reports Summary 100 B. Monthly Requirements 103 CHAPTER 4: BILLING AND ADMINISTRATION 105 I. Billing for Vaccine 105 II. Administration Fee 105 CHAPTER 5: PROGRAM EVALUATION 109 I. Provider Site Visits 109 A. Compliance Site Visits 109 B. AFIX Site Visits 110 II. Common Site Visit Structures 112 A. Combined TVFC Compliance and Initial AFIX Site Visit 112 B. TVFC Compliance Site Visit Only 113 C. Initial AFIX Site Visit Only 113 D. AFIX Follow-up Site Visit Only 113 E. Unannounced Storage and Handling Visit 113 III. Follow-Up Activities 114

7 Pg. 05 Table of Contents IV. Electronic Medical Records (EMRs) 116 V. Annual TVFC Provider Feedback Survey 116 CHAPTER 6: FRAUD AND ABUSE 119 I. Fraud and Abuse 119 II. Definitions 119 III. Examples 120 IV. Failure to Comply with TVFC Requirements 121 V. Fraud and Abuse Prevention 122 VI. Reporting Fraud and Abuse 122 CHAPTER 7: DOCUMENTATION REQUIREMENTS 125 I. Vaccine Record Keeping Requirements 125 II. The Texas Immunization Registry (ImmTrac2) 127 III. Addressing Vaccine Hesitancy 128 IV. Vaccine Adverse Events 129 CHAPTER 8: ADULT SAFETY NET PROGRAM 131 I. Adult Safety Net (ASN) Overview 131 II. Provider Types 132 III. ASN Enrollment 132 IV. ASN Patient Eligibility 133 A. Eligibility Criteria 133 B. Nineteen year Olds 134 C. Patient Eligibility Screening Record 134

8 Pg. 06 Table of Contents V. ASN Vaccine Formulary 136 VI. Provider Enrollment Requirements 136 A. Specific Terms of Agreement 136 B. Initial Enrollment 139 C. ASN Enrollment Visit 139 D. ASN Site Set-up 139 E. Vaccine Accountability 140 F. Provider Identification Number 140 G. Provider Change of Information 141 H. Annual Re-Enrollment 141 VII. Vaccine Ordering 141 A. Vaccine Choice 141 B. Vaccine Inventory Plan and Maximum Stock Levels _ 143 C. Increasing and Decreasing Maximum Stock Levels 144 D. Short-Dated Vaccine 144 E. Storage Capacity for Vaccine Orders 144 F. Vaccine Ordering in the Electronic Vaccine Inventory (EVI) System 144 G. Vaccine Ordering for ASN Providers without Internet Access 145 H. Vaccine Ordering for Newly Enrolled ASN Providers _ 146 VIII. Vaccine Storage 146

9 Pg. 07 Table of Contents IX: Vaccine Management 146 X. Vaccine Transfers 147 XI: ASN Billing and Administration 147 A. Billing for ASN Vaccine 147 B. ASN Administration Fee 148 XII: ASN Site Visits 148 A. Adult Immunization Standards 148 B. Types of Adult Site Visits 151 C. Site Visit Scheduling and Clinic Access 152 D. Components of the ASN Site Visit 153 E. Electronic Medical Record (EMR) Review 154 XIII. Mobile Vaccination Clinics 155 XIV. Reporting Doses Administered 156 XV. Fraud and Abuse 156 A. Definitions 156 B. Examples 156 C. Failure to Comply with ASN Requirements 158 D. Fraud and Abuse Prevention 158 E. Reporting Fraud and Abuse 159 CHAPTER 9: VACCINE INFORMATION STATEMENT (VIS) 161 CHAPTER 10: ORDERING FORMS AND LITERATURE 163 CHAPTER 11: IMMUNIZATION RESOURCES 165 TVFC Program Contact Information 167

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11 Pg. 09 Introduction to the 2018 Provider Manual and the Texas Vaccines for Children (TVFC) Program Vision: A Texas free of vaccinepreventable diseases. Mission: To remove barriers to complete and timely vaccination, increase vaccine coverage levels, and reduce the burden of vaccinepreventable diseases for all Texas infants, children, adolescents, and adults. Introduction to the 2018 Provider Manual and the Texas Vaccines for Children (TVFC) Program I. Provider Manual Information The Texas Department of State Health Services (DSHS) Immunization Unit has prepared the Texas Vaccines for Children (TVFC) Provider Manual. Consultation on the policies in this manual are conducted routinely with the Centers for Disease Control and Prevention (CDC), the Center for Medicare and Medicaid Services (CMS), DSHS, and other organizations. The purpose of the TVFC Provider Manual is to consolidate TVFC policies and information into one source. You may consult the manual as needed, in particular for the handling and management of TVFC vaccines. Throughout the year, the DSHS Immunization Unit will announce new policies via official policy letters and memorandums. The Provider Manual will undergo a comprehensive review annually. Both the manual and latest updates can be found on the dshs.texas.gov website. II. Public Health Law Establishing the Vaccines for Children (VFC) Program The federal Vaccines for Children (VFC) Program is authorized by the Omnibus Budget Reconciliation Act (OBRA), Section 1928 of the Social Security Act.

12 Pg. 10 Introduction to the 2018 Provider Manual and the Texas Vaccines for Children (TVFC) Program Funding from the federal VFC Program is supplemented with federal 317 funds that allow the federal purchase of vaccines and State General Revenue funds to support TVFC, and all immunization activities across Texas. Section 317 of the Public Health Service Act authorizes the federal purchase of vaccines to vaccinate children, adolescents, and adults. Section 317 discretionary funding also supports immunization program operations at the local, state, and national levels. TVFC enables over 4.3 million Texas children to have access to immunizations. This is accomplished through a network of support provided by the Department of State Health Services (DSHS) and with assistance from DSHS Health Service Regions (HSRs) and contracted Local Health Departments (LHDs). These organizations function as Responsible Entities to ensure compliance with state and federal standards and the effectiveness of vaccine distribution. As a provider, you will contact your Responsible Entity (DSHS HSR or LHD) for more information and for the details about required vaccine reporting. III. Vision and Mission of the DSHS Immunization Unit Vision: A Texas free of vaccine-preventable diseases. Mission: To remove barriers to complete and timely vaccination, increase vaccine coverage levels, and reduce the

13 Pg. 11 Introduction to the 2018 Provider Manual and the Texas Vaccines for Children (TVFC) Program burden of vaccine-preventable diseases for all Texas infants, children, adolescents, and adults. IV. Goals of the DSHS Immunization Unit Raise and sustain vaccine coverage levels for infants and children; Improve adolescent vaccine coverage levels; Improve adult vaccine coverage levels; Prevent and reduce cases of vaccine-preventable diseases; Maintain and improve public health preparedness; and Promote and practice the safe handling of vaccines and ensure the accountability of all program components. V. Goals of the TVFC Program Eliminate vaccine cost as a barrier to immunizations; Reduce the need for referrals by private providers to public clinics by keeping children in their medical home for comprehensive health care; and Provide a vaccine delivery system that is both efficient and effective for public and private providers.

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15 Pg. 13 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT I. Provider Eligibility Requirements To be eligible to enroll in the TVFC Program, providers must be one of the following: Medical Doctor (MD) Doctor of Osteopathy (DO) Nurse Practitioner (NP) Certified Nurse Midwife (CNM) Physician Assistant (PA) Registered Pharmacist (RPh) II. Provider Enrollment Requirements A. Specific Terms of Agreement In order to participate in the TVFC Program, each provider must agree to follow all program requirements. By signing the Texas Vaccines for Children (TVFC) Program Provider Agreement, the office and all practitioners associated with the medical office agree to the following: Submit a provider profile representing populations served by the facility annually; Screen for and document TVFC eligibility of all children at each immunization encounter;

16 Pg. 14 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Administer TVFC vaccine to all children 18 years of age or younger who meet the established eligibility criteria; Comply with appropriate vaccination schedules, dosages, and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP); Maintain all records related to the TVFC Program for at least five years and upon request, make these records available for review; Immunize eligible children with publicly supplied vaccine at no charge to the patient for the vaccine; Not charge an administration fee in excess of $14.85 per vaccine dose; Not charge an administration fee to Medicaid or Children s Health Insurance Program (CHIP) patients; Not deny administration of a TVFC vaccine to an eligible child because of the inability of the child s parent or guardian to pay the administration fee; Not send a patient to collections or charge additional fees for non-payment of a TVFC administration fee; Provide a copy of the most current Vaccine Information Statements (VIS) for each vaccine at the time of administration; Comply with the TVFC Program requirements for vaccine management, including ordering and proper storage and handling practices;

17 Pg. 15 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Not be cited or terminated from Medicaid or CHIP; Operate within the TVFC Program in a manner intended to avoid fraud and abuse; Participate in TVFC compliance site visits, including unannounced visits and other educational opportunities, as required; and Acknowledge that the DSHS Immunization Unit may terminate the agreement at any time for failure to comply with established requirements. If the agreement is terminated, the office and/or facility agrees to return all TVFC vaccines. In jurisdictions where there are mass vaccinators enrolled, or circumstances where the enrolled provider is not providing direct services and other parties are involved with administering the vaccines, all parties involved with implementing the clinics, including the medical director and other groups who are directly administering the vaccine, must sign the provider agreement. There must be a written agreement attached to the TVFC Program Provider Agreement detailing the responsibilities of each party involved. B. Initial Enrollment The first step in becoming a TVFC Provider is completing the TVFC Program Provider Agreement (E6-102) form. If you need assistance, you can call your Responsible Entity, Department of State Health Services Health Service Region (DSHS HSR) or

18 Pg. 16 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Local Health Department (LHD). The TVFC Program Provider Agreement is available on the DSHS Immunization Unit website at: htm. The TVFC Program Provider Agreement must be completed and updated each year. The agreement includes basic information about the facility and responsible provider. It also outlines the provider s responsibilities. The signed provider agreement must be received and processed by the TVFC Program prior to the clinic receiving state and federally funded vaccines. All licensed health care providers (MD, DO, NP, CNM, PA, or RPh) at the facility who have prescribing authority must be listed on the TVFC Program Provider Agreement. The listing must also include the signing clinician s information. Information required for the health care providers include: Provider Name; Title; Texas Medical/Nursing/Pharmacy License Number; and National Provider Identification (NPI). If the primary provider who signed the TVFC Program Provider Agreement leaves the practice, the program agreement must be updated at that time and signed by the new primary health care provider.

19 Pg. 17 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT The Provider Profile section of the TVFC Program Provider Agreement requests information about the provider s patient population, which includes the projection and identification of clients the clinic will serve in the upcoming year. Existing providers must provide accurate data from the previous 12 months and include the number of insured patients. These numbers must be specific to the clinic site and not combined with other clinics patient numbers. Data sources must include, but are not limited to: Immunization registry; Benchmarking; Number of Medicaid Claims or other billing data; and Client encounter data. The Responsible Entity will assist the provider through the enrollment process. The provider must designate two staff members as the primary and back-up TVFC vaccine coordinators. The two staff members will be informed by the Responsible Entity on how to complete the two (2) required CDC You Call the Shots training modules and the 2018 TVFC Provider Policy Training module upon initial enrollment. After completing the modules, the Certificates of Completion must be included with the TVFC Program Provider Agreement when it is returned to the DSHS HSR responsible for the county in which the provider is located.

20 Pg. 18 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT The provider may also choose to enroll in the Texas Immunization Registry (ImmTrac2) at this time. If the provider chooses to enroll, they will be provided information on how to submit the ImmTrac2 Registry form online. The TVFC Program checks the Office of the Inspector General s (OIG) List of Excluded Individuals or Entities to ensure that a pending provider is eligible to participate in the TVFC Program. Once the forms are approved by the TVFC Program, the provider s office is issued a Provider Identification Number (PIN). The PIN will be the clinic s vaccine account number for the duration of the clinic s enrollment in the TVFC Program. The PIN is required to be included on all TVFC forms and communications. Providers should enter their TVFC PIN into their ImmTrac2 user account. Information regarding ImmTrac2 may be found in Chapter 7: Documentation Requirements and on the ImmTrac2 webpage: The provider s office will be contacted by the Responsible Entity at this time, to schedule New Provider Training. C. TVFC Enrollment Visit All providers enrolling in the TVFC Program must receive an enrollment visit prior to receiving any vaccine through the TVFC Program. When the Responsible Entity visits the provider s office, a review of all storage units in the provider s office is

21 Pg. 19 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT The primary vaccine coordinator and back-up vaccine coordinator must both be available to meet with the Responsible Entity on-site for the duration of the initial enrollment visit. performed to ensure adequate and approved storage units are being used. A certified and calibrated data logger is placed in all units that will store the TVFC vaccine at this time, and logged for 10 business days before any TVFC vaccine is supplied. New Provider Training is also conducted on all TVFC Program policies to ensure that they are understood and followed. The initial enrollment visit typically takes a minimum of three (3) hours. The primary vaccine coordinator and back-up vaccine coordinator must both be available to meet with the Responsible Entity on-site for the duration of the initial enrollment visit. Information for new providers is available electronically at: New Provider Training includes: Review and confirmation that the provider and staff understand and can implement all TVFC Program requirements. Confirmation of the following: The provider has the proper equipment to maintain the TVFC vaccine; The staff understands how to properly store, handle, and monitor the TVFC vaccine; and The staff knows who to contact if problems arise.

22 Pg. 20 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Verification of the following: The provider has identified a primary and back-up vaccine coordinator; The provider has a plan for routine vaccine management; There are adequate water bottles in the refrigerator and frozen water bottles in the freezer; and Vaccine storage units have enough storage space to accommodate the provider s maximum capacity of vaccine. Review of the following forms: Vaccine Choice Selection; and Vaccine Management Plans. Training also includes review of the following: TVFC Program Provider Manual; Vaccine Ordering & Accounting (Electronic Vaccine Inventory [EVI] System); Vaccine Storage and Handling; Vaccine Quarantine Bag; Immunization Guidelines/Schedules; School/Day Care requirements; ImmTrac2; Forms and Literature; Vaccine Information Statements (VIS); Vaccine Adverse Events Reporting System (VAERS);

23 Pg. 21 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Vaccine Safety and other resources; Standards of Child & Adolescent Immunization Practices; Standards of Adult Immunization Practices (for providers who also administer an ASN Program site); Vaccine types; Administering vaccines; Schedule and intervals of vaccines; Anatomic sites; Needle sizes; and Contraindications and precautions. D. TVFC Site Set-up Once temperature charts are logged for 10 business days and temperatures are within the required range, the Responsible Entity begins the TVFC Program site set-up process and performs the following activities to ensure that vaccines are stored and handled appropriately: Checks the equipment: Placement of data loggers and their calibration certificates; and Verifies that plug guards are installed. Trains the new provider on essential processes: Vaccine choice options; Establishing maximum stock levels (MSLs); Online vaccine management in EVI;

24 Pg. 22 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Setting up the initial order; Creation of a Vaccine Management Plan; and Completion of the Temperature Recording Form. Checks that the following signage is displayed prominently within the clinic: Vaccine Management - Recommendations for Storage and Handling of Selected Biologicals Poster; How to Administer Injections" Poster; Guide to Contraindications Poster; Giving All the Doses" Chart; Refrigerator Warning Signs; and Do Not Unplug stickers on wall outlet and circuit breaker. Provides Recommended Immunization Schedules, Catch-up Schedules, Resource Lists, and other materials to the provider. If any of the items above were not provided to you as a new TVFC provider, please contact your Responsible Entity to have any missing items sent to you. E. Vaccine Accountability Vaccine accountability is a cornerstone of the TVFC Program and one of the highest priorities for the DSHS Immunization Unit. When a TVFC provider enrolls in the TVFC Program, they agree to the accountability requirements as a condition of participation.

25 Pg. 23 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT As of 2017, provider reenrollment takes place each November for the following year. All TVFC providers must ensure: TVFC vaccines are administered only to eligible children; Vaccine loss and waste are minimized and documented; Fraud and abuse (as defined in the TVFC policy manual) does not occur; TVFC vaccine inventory is accurately reported monthly; and Patients are screened at all immunization encounters for TVFC eligibility. F. Provider Identification Number A Provider Identification Number (PIN) will be assigned to the provider upon initial enrollment into the TVFC Program. The PIN will be the clinic s vaccine account number for the duration of the clinic s enrollment in the TVFC Program. The PIN is required to be included on all TVFC forms and communications. PIN numbers are associated with site visits, vaccine ordering, vaccine shipments, and for overall program operations. As a result, separate PIN numbers will be created for sites in different physical locations, even if they are supported by the same clinic staff. Providers should enter their TVFC PIN into their ImmTrac2 user account. Information regarding ImmTrac2 may be found in Chapter 7: Documentation Requirements and on the ImmTrac2 website:

26 Pg. 24 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT G. Provider Change of Information It is the TVFC provider s responsibility to maintain correct demographics, days and hours available to receive vaccine shipments, and profile information in the EVI system. The TVFC Program requires that when a provider changes location or if there is a new provider staff member acting as the primary and/or back-up vaccine coordinator, the Responsible Entity must be contacted immediately to inform them of the change. In addition, the TVFC Program requires that the provider update the information in EVI. New primary or back-up contacts are required to complete the CDC You Call the Shots and TVFC Provider Policy Training modules. The TVFC Program Provider Agreement and Provider Profile must also be updated if the provider s patient population changes and/or when the provider who signed the form is no longer associated with the clinic. Failure to properly update current clinic information may result in vaccine delays and possible vaccine loss. H. Annual Re-Enrollment As of 2017, provider re-enrollment will take place in November for the following year. The TVFC Program requires that the TVFC Program Provider Agreement and Provider Profile be updated annually. These forms are required for continued enrollment in the TVFC Program. TVFC providers that are a

27 Pg. 25 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT Federally Qualified Health Center (FQHC) or a Rural Health Center (RHC) should also submit a copy of the Centers for Medicare & Medicaid Services (CMS) letter. The TVFC provider s assigned primary and back-up vaccine coordinators are required to complete the required TVFC Provider Policy Training module and an online re-enrollment form each year. The two CDC You Call the Shots training modules are recommended during re-enrollment. Certificates of Completion for the TVFC Provider Policy Training module must be included with the signed enrollment form and will be submitted to their Responsible Entity electronically as part of the re-enrollment process. Vaccine shipments may be interrupted for TVFC providers who do not have current enrollment information on file. Note: For TVFC providers who are also enrolled in ASN, the TVFC and ASN re-enrollment forms have been combined into a single re-enrollment form for your convenience. I. Deputization of Clinics Deputization is used to support areas where an FQHC/RHC is unable to serve an underinsured population. If an FQHC/RHC is unable to serve a specified population, then DSHS HSRs and LHDs are the second line to serve as a "safety net" for the underinsured. Texas has implemented deputization of public health department clinics and LHDs. Delegation of Authority

28 Pg. 26 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT (DOA) or deputization, allows Texas FQHCs and RHCs to delegate authority for vaccinating underinsured children. Underinsured children served in FQHC, RHC, or deputized sites are eligible for federal VFC vaccine according to federal guidance. III. Provider Withdrawal from TVFC Any TVFC provider wanting to withdraw from the TVFC Program must contact their Responsible Entity to arrange for vaccine pick-up and assistance with final paperwork. Prior to withdrawal, the provider must complete a Provider Withdrawal Form and submit the form to their Responsible Entity. IV. Provider Suspension from TVFC If a provider violates the agreement and accountability requirements that are part of participating in TVFC, they may temporarily lose their ordering privileges. Suspension is dependent upon the severity of the non-compliance issues and/or failure to complete the TVFC required corrective action plans. TVFC corrective action plans are set in place to correct failures in vaccine management and non-compliance issues, including, but not limited to, failure to complete re-enrollment in a timely manner, failures in vaccine management, improper storage and handling practices, and failure to complete monthly reporting requirements. Providers may be asked to complete additional training as part of the corrective action plan.

29 Pg. 27 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT V. Provider Termination from TVFC A TVFC provider may be terminated from the TVFC Program for continued non-compliance with TVFC requirements, such as failure to complete required corrective actions associated with non-compliance. A TVFC provider may also be terminated for instances of fraud and abuse, as described in Chapter 6: Fraud and Abuse, of this manual. All TVFC providers are notified of their termination from the program via a signed letter from the Immunization Unit Director. Terminated TVFC providers are removed from the TVFC Program for a period of at least one year. Providers seeking re-enrollment following the minimum termination period must seek approval to re-enroll from the Immunization Unit s Vaccine Operations Group (VOG) Manager. VI. Re-enrollment after Termination In the event that a terminated provider is approved for reenrollment in the TVFC Program, they must complete the TVFC Provider Policy Training, participate in on-site education, and confirm that any outstanding issues have been resolved through a focused site review and assessment. TVFC providers terminated for instances of fraud and abuse may be considered for re-enrollment after one year, and only if

30 Pg. 28 CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT the provider is actively enrolled in Medicaid at that time and is not listed on OIG s List of Excluded Individuals and Entities (LEIE). The Immunization Unit Vaccine Management Group (VMG) Manager and Vaccine Operations Group (VOG) Manager, in consultation with the Immunization Unit Director, have the authority to determine whether or not a provider is eligible to re-enroll in the TVFC Program.

31 Pg. 29 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING I. Patient Eligibility Requirements A. TVFC Patient Eligibility Criteria Any child who is 18 years of age or younger and meets at least one of the eligibility criteria listed below is eligible to receive TVFC vaccine: Enrolled in Medicaid, or is Medicaid-eligible; Is uninsured; Is an American Indian or Alaskan Native (in accordance with 25 USC 1603); Is underinsured: A child who has commercial (private) health insurance, but coverage does not include vaccines; or A child whose insurance covers only selected vaccines (TVFC-eligible for non-covered vaccines only); or Enrolled in the Children s Health Insurance Program (CHIP). Insured children who have Medicaid as their secondary insurance (Medicaid-eligible) are eligible for TVFC vaccine and MUST NOT be refused vaccine administration due to their insurance status. If a child is TVFC-eligible in more than one eligibility category, the provider must select and document the eligibility category

32 Pg. 30 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING Screening for patient eligibility is the foundation of providerlevel accountability. If a child is TVFC-eligible in more than one eligibility category, the provider must select and document the eligibility category that will require the least outof-pocket expense for the parent or guardian. that will require the least out-of-pocket expense for the parent or guardian. Immigration status does not affect a child s eligibility for the TVFC Program. B. Children s Health Insurance Program Texas has an insurance program called the Children s Health Insurance Program (CHIP). An agreement between the DSHS Immunization Unit and CHIP stipulates that vaccines for eligible CHIP enrollees are purchased through the federal contract. Since children with CHIP are not eligible for the federal VFC Program, the DSHS Immunization Unit is reimbursed for doses administered to CHIP children based on CHIP enrollment data. The Vaccine Purchase Estimator Tool (VPET) is a tool provided by the CDC, which is used to estimate the number of vaccine doses required to fully vaccinate the state of Texas enrolled CHIP population with all applicable vaccines that are given quarterly. Each TVFC provider who administers VFC vaccines to CHIP children are required to bill CHIP for the vaccine administration fees. The CHIP pays the provider an administration fee and reimburses the DSHS Immunization Unit for the cost of the vaccines that were administered to CHIP children.

33 Pg. 31 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING C. Medicaid as Secondary Insurance If a child has private health insurance and Medicaid as secondary insurance, the child is TVFC-eligible. The provider can administer TVFC vaccine to the child and bill Medicaid for the administration fee. The parent or guardian of a child with Medicaid as secondary insurance should never be billed for a vaccine administration fee. D. Nineteen-year Olds Patients who are 19 years of age and who previously initiated a vaccination series under the TVFC Program, but have not completed the series, may complete the series using ASN vaccines regardless of their current health insurance status. The vaccine must be administered by an ASN provider at a DSHS HSR or LHD clinic. This provision only applies to patients that have not yet reached their 20th birthday. II. Patient Eligibility Screening Record Screening for patient eligibility is the foundation of providerlevel accountability. Screening all children at every immunization encounter and documenting eligibility screening at every visit is the only way to ensure that TVFC vaccine is used only for TVFC-eligible children. As such, full compliance on screening for eligibility is required. In the event improper screening results in the administration of TVFC vaccine to a

34 Pg. 32 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING non-tvfc-eligible child, providers are responsible for replacing the improperly used TVFC vaccine with private stock. Providers are required to document the eligibility of each child receiving TVFC vaccine at every visit. During a child s initial visit to the provider site, the provider must document the child s eligibility category per the TVFC Program guidelines and update the child s eligibility information during each future visit. Providers may use the Patient Eligibility Screening Record (C-10) or may electronically store patient demographic information. Eligibility screening must be completed/updated for all children at every visit, even including children with a previous record on file. A child s eligibility must be documented at every visit prior to vaccine administration. The parent, guardian, or provider may complete the Patient Eligibility Screening Record. Verification of parent/guardian response is not required. Documentation of eligibility screening must include the following elements: Date of screening; Child s name; Child s date of birth; Parent/Guardian s name; Clinic name; and Eligibility status for each visit.

35 Pg. 33 CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING The Patient Eligibility Screening Records must be kept on file with the patient s record, by all providers, for a minimum of five years after the last date of service to the patient and must be easily retrievable. It is also acceptable for providers to utilize electronic medical records (EMR) system to capture and save the information from the Patient Eligibility Screening Records as long as the EMR captures all the required eligibility elements.

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37 Pg. 35 CHAPTER 3: VACCINE MANAGEMENT CHAPTER 3: VACCINE MANAGEMENT I. Approved Vaccines The TVFC Program supplies all the Advisory Committee on Immunization Practices (ACIP) recommended vaccines and toxoids to enrolled providers. Diphtheria and Tetanus toxoids, adsorbed (DT) Diphtheria-Tetanus toxoids and acellular Pertussis (DTaP) Diphtheria-Tetanus toxoids and acellular Pertussis, Hepatitis B, and inactivated polio (DTaP-Hep B-IPV) Diphtheria-Tetanus toxoids and acellular Pertussis, inactivated polio, and Haemophilus influenzae type b (DTaP- IPV/Hib) Diphtheria-Tetanus toxoids and acellular Pertussis and inactivated polio (DTaP-IPV) Hepatitis A (Hep A) Hepatitis B (Hep B) Hepatitis A and Hepatitis B (Hep A - Hep B) combination Haemophilus influenzae type b (Hib) Human Papillomavirus (9vHPV) Influenza (Flu) Inactivated polio (IPV) Measles, Mumps, and Rubella (MMR) Measles, Mumps, Rubella, and Varicella (MMRV)

38 Pg. 36 CHAPTER 3: VACCINE MANAGEMENT Meningococcal groups C and Y and Haemophilus influenzae b (tetanus toxoid) (HIBMENCY) Meningococcal Conjugate (MCV4) Meningococcal Serogroup B (MenB) Pneumococcal Conjugate (PCV13) Pneumococcal Polysaccharide 23-valent vaccine (PPSV23) Rotavirus (RV) Tetanus and diphtheria toxoids, adsorbed (Td) Tetanus and diphtheria toxoids and acellular Pertussis (Tdap) Varicella II. Vaccine Ordering A. Vaccine Choice The TVFC Program supplies all ACIP recommended vaccines and toxoids to enrolled providers. Providers participating in the TVFC Program are required to offer all ACIP recommended vaccines to the eligible populations they serve, including influenza vaccine. House Bill 448 from the 81st Texas Legislature gives TVFC providers the opportunity to choose their preferred brands and presentations of vaccines from their available formularies. The provider who signs the TVFC Program Provider Agreement can choose vaccine brands and presentations. For new TVFC providers, the Responsible Entity (DSHS HSR or LHD) will create the initial vaccine order using the Pediatric Biological

39 Pg. 37 CHAPTER 3: VACCINE MANAGEMENT Order Form (EC-68-1). The Pediatric Biological Order Form will reflect the provider s vaccine choices, their maximum stock level (MSL), and order quantity. Each quarter, TVFC providers will have the opportunity to choose the brand and presentation for each TVFC vaccine in the Electronic Vaccine Inventory (EVI) system. They can change or adjust specific vaccine brands, presentations, and percentages within each vaccine family (i.e., DTaP), or take no action to maintain the current selections. Providers are encouraged to review all choice selections on a quarterly basis. A provider s vaccine coordinator may complete the process, however, the provider who signed the TVFC Program Provider Agreement must be consulted and agree to the vaccine choices. The vaccine choices, as well as the person making the changes, are captured electronically in EVI. TVFC providers are notified prior to the opening and closing of the vaccine choice period. Only vaccines supplied by the Centers for Disease Control and Prevention (CDC) to the TVFC Program will be available for vaccine choice. In the event that a chosen vaccine is not available, the TVFC Program has the authority to replace the unavailable vaccine with a comparable substitution until the chosen vaccine becomes available.

40 Pg. 38 CHAPTER 3: VACCINE MANAGEMENT The vaccine inventory plan requires all enrolled providers to maintain a 75-day supply of vaccine inventory. The suggested quantity is the maximum number of doses a provider needs to maintain the 75-day inventory. Note: Vaccine choice does not apply in the event of a disaster or public health emergency, terrorist attack, hostile military or paramilitary actions, or any other extraordinary law enforcement emergency. B. Vaccine Inventory Plan and Maximum Stock Levels The vaccine inventory plan requires all enrolled providers to maintain a 75-day supply of vaccine inventory. All Providers should place vaccine orders monthly. The CDC recommends that providers place orders when they have a four week supply of vaccine available, to ensure there is enough vaccine in stock to allow for any potential delays. The CDC also recommends smaller, more frequent orders rather than larger orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the vaccine storage unit. Providers may place additional orders. Providers are not required to order each month, but as needed to maintain a 75-day supply of vaccine. The maximum stock level (MSL) is a calculated peak dose inventory (per vaccine type). The suggested quantity is the maximum number of doses a provider needs to maintain the 75-day inventory. Providers must take into account their current inventories and unit storage capacities when placing orders to ensure that they have adequate storage for all vaccines. Special circumstances may allow for monthly MSL adjustments on rare occasions. The provider must

41 Pg. 39 CHAPTER 3: VACCINE MANAGEMENT request a review and obtain permission from their Responsible Entity prior to ordering more than their suggested MSL quantity. Upon initial enrollment, the Responsible Entity will work with the TVFC provider to develop MSLs based on the provider s patient population. All MSLs are monitored and revised in EVI. Newly enrolled providers may have their MSL reassessed by their Responsible Entity after 6 months with the TVFC Program. MSLs are recalculated on a monthly basis based upon doses administered data. The monthly average MSL is determined from this data. Providers may not order vaccine in excess of their suggested quantity without permission from their Responsible Entity. See Section VIII. Reporting Requirements, for more detail of the monthly reporting requirements. C. Increasing and Decreasing Maximum Stock Levels A provider s MSL may be increased or decreased at any time if the number of TVFC-eligible children served changes, or if there are any applicable changes to the status of the facility that might impact vaccine usage. TVFC providers can notify their Responsible Entity if they feel a change is needed. Changes may also be made by the DSHS Immunization Unit based upon the data gathered during the calendar year.

42 Pg. 40 CHAPTER 3: VACCINE MANAGEMENT To determine appropriate MSLs for the Back-to-School season, calculations will be done by the DSHS Immunization Unit to determine the new MSL utilizing the reporting data from the previous calendar year. Providers that consistently order below their suggested quantity may have their MSL lowered. Providers that place multiple orders during a given month may have their MSL increased. Final determination is made depending on the frequency and duration of the provider s ordering pattern. D. Short-Dated Vaccine Short-dated vaccines are those vaccines that are within 90 days of expiration. Placing orders according to the established MSLs and rotating vaccines so that short-dated vaccines are used first will help to prevent losses due to expiration. Clinic staff must note vaccine expiration dates when physically counting inventory at the end of the month. Short-dated vaccine must be used first. Vaccine surplus kept in inventory increases the risk of vaccine expiration and increases the amount of loss in the event of refrigerator failure. When ordering vaccines, TVFC providers must have no more than the designated MSL in stock and including the order. Each TVFC provider is required to notify their Responsible Entity 90 days prior to the expiration of vaccine. If the provider is unable to administer the vaccine prior to expiration, the

43 Pg. 41 CHAPTER 3: VACCINE MANAGEMENT Monthly reporting in EVI is required for all TVFC providers, whether or not an order is placed. Responsible Entity may assist with moving the vaccine to another provider site, provided another provider is willing to accept the vaccine. Vaccine diluents, the liquid mixed with a freeze-dried vaccine to reconstitute it, must be managed in the same manner as vaccines. The expiration date of diluents must be checked prior to every reconstitution. The TVFC providers must also rotate diluent stock to use the shortest expiration date first. If vaccines are allowed to expire, they are considered nonviable. Expired vaccines must be placed in a Vaccine Quarantine Bag clearly labeled Do not use and removed from storage units. E. Storage Capacity for Vaccine Orders A TVFC provider must have adequate refrigeration and/or freezer space to accommodate a maximum order based on their MSL, including flu. A TVFC provider must also take into consideration the space needed for their private stock when calculating storage capacity. F. Vaccine Ordering in the Electronic Vaccine Inventory (EVI) System The TVFC Program uses the EVI system for vaccine ordering. EVI allows TVFC providers to manage their vaccine inventory online. All vaccine orders will be placed in EVI unless internet

44 Pg. 42 CHAPTER 3: VACCINE MANAGEMENT access is unavailable. A TVFC provider may be held responsible for vaccine loss that is a result of erroneous information entered into EVI. Prior to placing an order, TVFC providers are required to enter the following information into EVI: Verification of days and hours of operation that the provider is available to receive the vaccine; The delivery address; Primary and back-up point of contact information; All vaccine received; All vaccine doses transferred; Any expired, spoiled, or wasted vaccine; All doses administered within the last calendar month; A physical count of all vaccines by brand, presentation, lot number, and expiration date within two days of placing their online order (C-33 report); If applicable, all doses that will expire within 90 days; and Any scheduled clinic closures (including holidays) must be noted in the comments section of the order. Monthly reporting is required for all TVFC providers, whether or not an order is placed.

45 Pg. 43 CHAPTER 3: VACCINE MANAGEMENT Providers must also submit the following reports to their Responsible Entity via fax or a scanned copy: Temperature logs (EC-105) Vaccine Loss Reports, if applicable Borrowing form (EF ), if applicable. All orders placed in EVI will be reviewed and approved by the Responsible Entity pending the TVFC provider s completion and submission of the required monthly reporting forms and resolution of any outstanding issues. Incomplete or inaccurate online orders will be placed on Hold, pending corrections by the TVFC provider, which may cause orders to be delayed. Each TVFC provider must abide by their established MSLs when ordering vaccine. EVI uses the TVFC provider s MSLs and current inventory to determine a suggested quantity of vaccine on the Place Order tab. Any orders exceeding the MSL will be reviewed on a case-by-case basis. Vaccine loss is captured electronically in EVI. When a TVFC provider documents, as required, any expired, spoiled, or wasted vaccine in EVI, the system will automatically place subsequent orders on Hold until the nature of the loss has been determined.

46 Pg. 44 CHAPTER 3: VACCINE MANAGEMENT All TVFC providers are able to view their order status on the Order History page of EVI. Status definitions are the following: OPEN HOLD PACKED SHIPPED RECEIVED Indicates that the order is ready to be sent to the distributor for shipment three business days from the date the order is placed and after approval by Responsible Entity. Indicates that the order has not been approved, pending the review of a Vaccine Loss Report (VLR), the need for additional documentation, or other identified issues. Indicates that the order is with the distributor. Indicates that the order is in transit or a transfer has been conducted in EVI. Indicates that the TVFC provider has received the order or transfer. If any discrepancy is found between the orders placed, the packing list, the fax confirmation, or the doses received, TVFC providers are instructed to immediately contact their Responsible Entity for resolution. All vaccines must be appropriately stored immediately upon receipt regardless of any errors in the order.

47 Pg. 45 CHAPTER 3: VACCINE MANAGEMENT G. Vaccine Ordering for TVFC Providers without Internet Access A TVFC provider without access to the internet will contact their Responsible Entity, who will then enter the TVFC provider s order online. The TVFC provider will submit the following paper forms to their Responsible Entity so that vaccine order can be placed: Monthly Biological Report (C-33); Pediatric Biological Order Form (EC-68-1); and Temperature Recording Form(s) (EC-105). The Monthly Biological Report is reviewed by their Responsible Entity to ensure that the beginning inventory matches the last month s ending inventory. Calculations must be correct and the net loss or gain must not exceed five doses of any one vaccine. Any corrections needed are reported to the TVFC provider so the records can be corrected prior to ordering. H. Vaccine Ordering for Newly Enrolled TVFC Providers Newly enrolled TVFC providers are set up for vaccine ordering in EVI during New Provider Training with their Responsible Entity. The order is placed by the TVFC provider as part of the training.

48 Pg. 46 CHAPTER 3: VACCINE MANAGEMENT The Responsible Entity collects and reviews the following paper reports prior to placing the new TVFC provider s vaccine order: Pediatric Biological Order Form (EC-68-1); and Temperature Recording Form(s) (EC-105). I. Ordering Influenza Vaccine ACIP recommends routine annual influenza vaccination of all persons aged 6 months and older. Additionally, as a provider for the TVFC Program, you have agreed to administer all ACIP recommended vaccines to the eligible population that you serve. The pre-book is a commitment by the TVFC provider to order doses for the upcoming flu season. Annual influenza vaccine orders are typically pre-booked by TVFC providers in the first quarter of each calendar year. TVFC providers will use an online survey tool to select their vaccine choices for the upcoming season. The link to the survey is made available to the TVFC providers in a memo and includes a brief description of the influenza vaccines available for the upcoming flu season. If the orders exceed the expected number of eligible children from the TVFC provider profile, providers may be contacted for an explanation. If a TVFC provider who sees TVFC-eligible children does not order influenza vaccine for the upcoming season, they must complete a separate section of the survey explaining why they are not ordering the vaccine. A TVFC

49 Pg. 47 CHAPTER 3: VACCINE MANAGEMENT provider is required to follow all ACIP recommendations, including the administration of influenza vaccine. A TVFC provider who does not order influenza vaccine will receive a follow-up phone call from their Responsible Entity or the TVFC Program. The TVFC Program orders a limited quantity of additional doses to account for new TVFC providers who enroll after the closing of the pre-book survey. Other unforeseen situations that may occur between the pre-book and the actual release of the vaccines to the TVFC Program may also be considered for first round allocation. Influenza vaccine will be allocated to TVFC providers as it is made available to Texas. The TVFC Program typically completes all pre-booked and new TVFC provider orders first as part of the first round allocation. A second influenza survey tool will be re-opened for TVFC providers that did not order during the pre-book period. TVFC Providers who wish to add to their original order may also order additional vaccine during this second round. When the first and second round orders are filled entirely, any remaining influenza vaccine will be added to the EVI system for general ordering by all TVFC providers. If there is an additional need for influenza vaccine, the TVFC Program will contact other TVFC providers in Texas for a possible vaccine transfer or place an additional order with the CDC.

50 Pg. 48 CHAPTER 3: VACCINE MANAGEMENT The TVFC Program recognizes that both TVFC supplied and privately purchased influenza vaccines may arrive at a TVFC provider's office at different times during the influenza season. Even if this occurs, the TVFC Program does not allow TVFC providers to borrow TVFC influenza doses for administration to their non-tvfc-eligible clients. J. Vaccine Ordering for Mass Vaccination Clinics Mass vaccination clinics may be set up for seasonal vaccines, such as influenza, to protect a large group of patients. Routine transport of vaccine is not recommended due to the risk of compromising the cold chain and vaccine viability. However, because most temporary mass clinics typically require vaccine transport on the day of the clinic, these temporary clinics (e.g., school located clinic) require enhanced storage and handling practices. The TVFC provider must develop mass vaccination protocols to ensure outreach efforts meet all TVFC requirements, including: Showing the established vaccine needs (e.g., provider profile); A plan for overseeing vaccine ordering for each clinic site to ensure that proper amounts of TVFC stock are transported on each clinic day; The type of portable storage unit being used;

51 Pg. 49 CHAPTER 3: VACCINE MANAGEMENT It is important to recognize and store vaccine shipments immediately upon receipt to ensure vaccine viability. How the cold chain will be maintained from the beginning to the end of the mass vaccination clinic; and Each site location should be documented on the Temperature Recording Form (EC-105). The TVFC provider s Responsible Entity must review and approve mass vaccination plan prior to initiation of the mass vaccination clinics. Specific storage and handling requirements for mass vaccination clinics is discussed in the storage and handling section of this Chapter, in Section V- Vaccine Storage and Handling, subsection F. Mass Vaccination Clinic Requirements. III. Vaccine Distribution A. Vaccine Distributors The TVFC Program uses two vaccine distribution centers: McKesson Specialty, a third party distributor which ships the majority of TVFC vaccines; and Merck, the manufacturer of Varicella vaccines, which ships directly to providers. B. Receiving Vaccine Orders The TVFC Program requires that TVFC providers always accept vaccine shipments and never refuse or return the shipments without specific instructions from the TVFC Program or from

52 Pg. 50 CHAPTER 3: VACCINE MANAGEMENT their Responsible Entity. The TVFC provider must ensure that the accurate clinic address and delivery hours are entered into EVI. In order for TVFC providers to receive vaccine shipments, appropriate staff must be on site and available at least one day a week other than Monday and for at least four consecutive hours during the hours of 8:00 a.m. 5:00 p.m. Each TVFC provider establishes the hours available to accept vaccine shipments when they submit their initial vaccine order in EVI. The vaccine will be shipped so that it will arrive when the provider is available to accept the order. The TVFC provider will not be able to change their available hours in EVI once an order is placed. The TVFC provider will be held responsible for incomplete or erroneous information entered into EVI which can result in vaccine loss. The TVFC provider can expect their approved orders approximately two to three weeks after placing their online order in EVI. It is important to recognize and store vaccine shipments immediately upon receipt to ensure vaccine viability. All TVFC providers are required to train their staff on what a vaccine shipment looks like and have a vaccine management plan in place to ensure the vaccine is stored quickly and correctly upon arrival.

53 Pg. 51 CHAPTER 3: VACCINE MANAGEMENT The following steps are required when a vaccine shipment arrives: Check actual vaccines received against packing list to verify all vaccines have been received; Inspect the vaccines and check the temperature strip or other temperature reading device; Ensure adequate amount of diluent is included for those vaccines which require reconstitution (e.g., MMR, Varicella); Determine the length of time the vaccine was in transit by looking at the ship date and time on the packing list or the transport tracking link in EVI; Immediately contact the Responsible Entity when: o The appropriate quantity and type of vaccine or diluent is not received; o Vaccines have been received in error; or o Vaccines appear to be compromised. Appropriately store all vaccines immediately upon receipt regardless of any errors in quantity, shipping, or transport; Check expiration dates and rotate stock to ensure shortdated vaccines are used first; and Immediately enter receipt of the vaccines in EVI. Each package shipped from McKesson comes with a temperature monitoring strip(s). If the monitor strip(s) indicates, or if staff suspects that the cold chain has been

54 Pg. 52 CHAPTER 3: VACCINE MANAGEMENT compromised, staff must immediately follow the instructions in subsection D below, Vaccines Received Warm or Questionable. All TVFC providers are required to record the vaccine at the time of receipt in EVI to maintain correct online vaccine inventory. C. Manufacturer and Distributor Maintenance of the Cold Chain The manufacturer and distributor pack the vaccine using qualified pack-outs and containers that have been tested to maintain appropriate temperatures. Refrigerated vaccine is packed to maintain the cold chain for 72 hours. The vaccine will be shipped using high quality cardboard boxes with Styrofoam inserts. Packages are imprinted with Temperature Sensitive Product and include red stickers reading Refrigerate upon Arrival to alert clinic staff to refrigerate contents immediately upon arrival. Varicella and MMRV are directly shipped from Merck. Merck products are shipped frozen with a four-day pack-out. If the vaccine arrives within four days of the pack date on the invoice, then the vaccine is viable. The TVFC provider must immediately place all vaccines in proper storage. If the vaccine arrives outside of the four-day pack-out, then the TVFC

55 Pg. 53 CHAPTER 3: VACCINE MANAGEMENT provider must immediately place the vaccine in a Vaccine Quarantine Bag provided by the TVFC Program, store the vaccine properly, notify their Responsible Entity, and contact the manufacturer. D. Vaccines Received Warm or Questionable Vaccines must always be stored properly, even if viability is questionable. If vaccines are received warm, damaged, or in an otherwise questionable state, the TVFC provider must immediately contact their Responsible Entity. Questionable vaccine cannot be identified visually and must be placed in a Vaccine Quarantine Bag provided by the TVFC Program and separated in proper storage until viability can be determined. Examples of questionable (potentially non-viable) vaccines: Vaccine shipment received with temperature indicator strip showing out of range; Vaccine is warm to touch; or Vaccine is received damaged. If vaccine viability is questionable upon receipt, a provider must: Separate the questionable vaccine in a Vaccine Quarantine Bag and place questionable vaccines in the refrigerator or freezer, as applicable, until viability can be determined. Do not write on the vaccine itself.

56 Pg. 54 CHAPTER 3: VACCINE MANAGEMENT Contact the manufacturer immediately to determine the viability of the vaccine. If the manufacturer is unable to respond, the provider must inform their Responsible Entity. Contact your Responsible Entity on the same day the vaccine arrived at the TVFC provider s office. Any calls received after the day of delivery will result in the CDC s liability for vaccine replacement, regardless of the cause of the temperature excursion. This documentation must be maintained with the provider s TVFC records for a minimum of five years. Inform the Responsible Entity of the determination of the viability of the vaccine. All TVFC providers must keep the vaccine quarantined and wait for the instructions for replacement, reporting loss, etc. Note: Vaccine returns due to shipping issues are required to be returned to McKesson within 48 hours. Merck requires that the request for replacement be received within 15 days of the original shipment. E. Vaccines Received in Error TVFC providers must call their Responsible Entity immediately upon receipt of vaccines that are received in error. The TVFC provider may opt to keep the vaccine if they have storage capacity and will administer the doses. If the TVFC provider cannot absorb the vaccine into their stock, then their Responsible Entity may assist in redistributing the vaccine to other TVFC providers to prevent vaccine wastage.

57 Pg. 55 CHAPTER 3: VACCINE MANAGEMENT Spoiled and expired vaccine must be returned to the distributor within 6 months of the loss. IV. Vaccine Loss A. Expired, Spoiled, and Wasted Vaccine The Immunization Unit requires all unopened or unused vials and syringes of expired TVFC vaccines be returned to the thirdparty distributor (McKesson). Vaccine manufacturers reimburse CDC for the federal excise tax portion of the cost of the vaccine. Therefore, providers should not discard any vaccine unless specifically directed by the DSHS Immunization Unit, DSHS HSR or LHD. Any exception to this rule will be communicated by the DSHS Immunization Unit on a case-by-case basis. Providers are to immediately notify their Responsible Entity of vaccine cold chain failure events or vaccine wastage incidents involving TVFC vaccines upon discovery of the incident. Expired or spoiled vaccine is any non-viable vaccine in its original container such as a vial or syringe that can be returned for excise tax credit. This includes expired vaccine or vaccine that has been spoiled as a result of the following: Natural disaster/power outage; Refrigerator being too warm or too cold; Freezer too warm; Failure to store vaccine properly upon receipt; Vaccine spoiled in transit; Mechanical failure; or Recall.

58 Pg. 56 CHAPTER 3: VACCINE MANAGEMENT Wasted vaccine is any non-viable vaccine that cannot be returned for excise tax credit. This includes: Vaccine drawn into the syringe but not administered; Vaccine in open vial multi-dose vial where all doses have not been administered (partial vial); Compromised vial (e.g., due to a drop causing damage to vial integrity or sterility); Lost vial; Vaccine drawn into the syringe but refused by the patient; Incorrect vaccine that has been prepared for patient; and/or Incorrect diluent drawn for vaccine. Wasted and expired/spoiled vaccines should be removed from the storage unit, labeled Do Not Use, and stored pending return to distributor. Expired diluents do not need to be returned. Lost vials are expected to be adjusted on the provider inventory. Vaccine loss must be documented on a Vaccine Loss Report (VLR) electronically in EVI no later than four days past the date of the incident(s). All vaccine returns to McKesson must occur within six months of the loss. The third party distributor, McKesson, will document Texas losses and return vaccines to the manufacturer for excise tax credit.

59 Pg. 57 CHAPTER 3: VACCINE MANAGEMENT B. Procedures for Vaccine Loss Every dose of vaccine that is lost (wasted, spoiled, or expired) must be reported to the TVFC Program on a Vaccine Loss Report electronically generated in EVI. Spoiled and expired vaccine must be returned to the distributor within 6 months of the loss. Providers are to follow the procedures listed below when vaccine loss occurs: Remove expired/spoiled vaccine from the vaccine storage unit and place in a Vaccine Quarantine Bag. Contact your Responsible Entity immediately with the following information: Antigen; Lot number; Expiration date; and Reason for expiration/loss. If storage was compromised, provide the Responsible Entity with amount of time product was out-of-range and the highest and lowest temperatures recorded (this information may be gathered from the data logger download). Document the vaccine loss on the Vaccine Loss Report electronically generated in EVI within four days past the date of the incident of loss. Explain the cause(s) of the loss and outline the steps taken to ensure vaccines will be protected in the future.

60 Pg. 58 CHAPTER 3: VACCINE MANAGEMENT The Vaccine Loss Report must also be printed and signed by the medical provider who signed the TVFC Program Provider Agreement or any medical personnel with prescribing authority listed on your Provider Agreement. The report must then be ed or faxed to the Responsible Entity within four days of the date of the loss. The Vaccine Loss Report includes the following sections: Clinic demographics; Date loss was discovered; Type of loss; Reason for loss; Corrective action taken to avoid re-occurrence; List of vaccines by antigen, manufacturer, lot number, expiration date, and number of doses lost. TVFC providers will receive a shipping label from McKesson for returning non-viable vaccine, if applicable. The provider must wait until UPS returns for the pickup to avoid paying a fee. Providers must ensure that all vaccines listed on that Vaccine Loss Report are included in the box for return (except for dropped or broken vials/syringes). If more than one box is used to return non-viable vaccine, providers must indicate on the Vaccine Loss Report the number of the box in which the vaccine is being shipped (e.g., Box 1 of 2, Box 2 of 2, etc.).

61 Pg. 59 CHAPTER 3: VACCINE MANAGEMENT Any wasted vaccine listed on the Vaccine Loss Report (dropped or broken vials/syringes) should be marked through with a single line as they are not included in the box for return. Important Note: Only unbroken, sealed vaccine vials/syringes may be included for return. Broken vials/syringes, open multidose vials, or exposed syringe needles should NEVER be included in the box. Providers will have to wait until UPS returns to their office with the next delivery to return the box with the non-viable vaccines. If the provider calls to schedule a pickup, the provider will be charged a pick up fee. McKesson will not schedule pickups on behalf of TVFC providers unless special arrangements are made by the DSHS Immunization Unit. TVFC providers who have lost vaccine as a result of improper temperature storage must assess how long the vaccines were stored improperly and how many children may have received the affected vaccines. The signing clinician determines whether or not children will need to be recalled and revaccinated. The TVFC Program will not provide the vaccine for recalled children in these circumstances. The clinic will assume all financial responsibility for the cost of vaccines for recalls. Providers must contact their Responsible Entity with the determination from the signing clinician.

62 Pg. 60 CHAPTER 3: VACCINE MANAGEMENT Refrigerator and freezer units must be large enough to hold the year s largest inventory without crowding. C. Negligent Vaccine Loss TVFC providers will be held responsible for vaccine losses due to negligence. Vaccine negligence may include, but is not limited to, the following: Vaccine stored improperly; Vaccine left out of the refrigerator or the freezer; Refrigerator or freezer unplugged (plug guard, that covers the outlet, is not used); Vaccine transported inappropriately (appropriate cold chain was not maintained); Improper monitoring of temperatures in refrigerator or freezer; Allowing vaccine to expire without notifying the Responsible Entity 90 days in advance of the expiration date; Refrigerator or freezer door left open (causing temperature excursion); Refusal of a vaccine shipment; Vaccine not stored properly upon receipt; Compromised vial (e.g., due to a drop causing damage to vial integrity or sterility); Lost vial; Incorrect vaccine prepared for patient; and/or Incorrect diluent drawn for vaccine.

63 Pg. 61 CHAPTER 3: VACCINE MANAGEMENT V. Vaccine Storage and Handling Proper receipt and storage of a vaccine delivery is important to maintain the vaccine cold chain. The cold chain, or temperature monitoring, begins with the cold storage unit at the manufacturing plant, extends through transport of vaccines to the distributor, and continues through the delivery to and storage at the provider facility, and ends with administration of vaccine to the patient. Exposure to heat, cold, or light at any step in the cold chain can damage vaccines, resulting in loss of potency. Failure in the cold chain can be costly. Should there be a failure in the cold chain; the result can mean extra doses for patients, increased cost for providers, and damage to public confidence in vaccines. A loss of public confidence in vaccines can lead patients to refuse revaccination and remain unprotected from serious vaccine-preventable diseases. By maintaining the vaccine cold chain, your facility can avoid incurring the additional costs associated with loss and replacement of vaccines, as well as the need to recall patients for revaccination.

64 Pg. 62 CHAPTER 3: VACCINE MANAGEMENT A. Refrigerator and Freezer Requirements TVFC providers are required to have appropriate equipment that can store vaccine and maintain proper conditions: Refrigerator and freezer units must be large enough to hold the year s largest inventory without crowding. Two types of refrigerator units are acceptable for storage: a stand-alone, single-purpose refrigerator or a pharmaceutical/purpose-built unit. The CDC recommends stand-alone freezers specifically manufactured to maintain very cold temperatures. These freezers are acceptable for the storage of Varicella, MMRV, or MMR vaccines only. A frost-free unit with an automatic defrost cycle is preferred. Combination units, if used, must have separate thermostats for the refrigerator and freezer compartments. The CDC recommends not using both the freezer and refrigerator section of a dual unit. Each unit should serve as either a freezer or a refrigerator. Dorm-style and small combination refrigerator and freezer units with a single external door are never allowed for the storage of TVFC vaccine. The refrigerator compartment must maintain temperatures between 36 F and 46 F (2 C and 8 C) for vaccine viability. The refrigerator temperature should be set at midrange, 40 F (4 C).

65 Pg. 63 CHAPTER 3: VACCINE MANAGEMENT The freezer compartment must maintain temperatures between -58 F and +5 F (-50 C and -15 C) for vaccine viability. An alarm system and back-up generator are recommended to help reduce vaccine loss when unexpected temperature fluctuations occur. Refrigerators and freezers storing vaccines must be plugged directly into a wall outlet with a plug guard. Multi-strip outlets must not be used. Each refrigerator or freezer must contain a sufficient number of water bottles to help maintain proper storage temperature during peak usage of the unit. Peak usage is considered when there is frequent opening and closing of unit doors or a power failure. Water bottles serve as a physical barrier to prevent placing vaccines in areas where there is greater risk for temperature excursions. Note: The CDC recommends that water bottles should not be used in pharmaceutical/purpose-built units if the manufacturer indicates that water bottles negatively impacts the functionality of the unit. Depending on the size of the unit, the amount of vaccine stored, and the time of year, sufficient may differ from one clinic to the other. However, there must be adequate water bottles in each refrigerator and adequate frozen water bottles in

66 Pg. 64 CHAPTER 3: VACCINE MANAGEMENT each freezer to help maintain proper storage temperature during peak usage of the unit or until vaccines can be moved to another refrigerator or freezer. For the refrigerator: Make sure the refrigerator door is closed completely; Replace crisper bins with water bottles to help maintain a consistent temperature (unless used for other medical equipment or supplies); Label water bottles Do Not Drink ; Post Do Not Unplug signs on the refrigerator and by the electrical outlet; Place water bottles in unit doors carefully so they cannot dislodge and prevent the doors from closing or weigh down the door so much that it does not seal tightly; Place water bottles on the top shelf of the refrigerator; Do not use the top shelf for vaccine storage; Do not put food or beverages in the refrigerator; Do not put vaccines in the doors or floor of the refrigerator; Do not drink from or remove the water bottles; Leave 2-3 inches between all vaccine and the refrigerator walls; Store each type of vaccine or diluent in a separate container;

67 Pg. 65 CHAPTER 3: VACCINE MANAGEMENT Place vaccines with the earliest expiration dates in front of those with later expiration dates; Whenever possible, store diluent with the corresponding refrigerated vaccine. Diluents should never be frozen; Attach labels to shelves and containers to clearly identify where each type of vaccine and diluent is stored. If diluent is stored separately from the corresponding vaccine, label the container where it is stored; Store vaccines and diluents with similar packaging or names (e.g., DTaP and Tdap or Hib and HepB) or with both pediatric and adult formulations on different shelves to minimize the risk of administration errors; Make sure to label the formulation pediatric or adult, if applicable; Always store vaccines in their original packaging with lids closed until ready for administration; Never store loose vials or manufacturer-filled syringes outside of their packaging; Do not pack a storage unit too tightly. This can restrict air circulation and impact temperature; Vaccines should be centrally stored within the unit; and Store privately purchased vaccine on different shelves from TVFC to minimize the risk of administering TVFC vaccine to non-eligible patients. TVFC vaccines should be clearly marked to differentiate them from privately purchased vaccines.

68 Pg. 66 CHAPTER 3: VACCINE MANAGEMENT For the freezer: Make sure the freezer door is closed completely; Use frozen water bottles to help maintain a consistent temperature; Place water bottles against the walls, in the back, on the floor, and in the door racks; Place water bottles in unit doors carefully so they cannot dislodge and prevent the doors from closing or weigh down the door so much that it does not seal tightly; Post Do Not Unplug signs on the freezer and by the electrical outlet; Do not put food in the freezer; Leave 2-3 inches between all vaccines and the freezer walls; Do not store vaccines in the freezer doors; Avoid storing vaccines in any part of the unit that may not provide stable temperatures or sufficient air flow, such as directly under cooling vents or shelves on the door; Store each type of vaccine in a separate container; Vaccines should be centrally stored within the unit; Place vaccines with the earliest expiration dates in front of those with later expiration dates; Attach labels to shelves and containers to clearly identify each type of vaccine;

69 Pg. 67 CHAPTER 3: VACCINE MANAGEMENT Store vaccines with similar packaging or with both pediatric and adult formulations on different shelves to minimize the risk of administration errors; Store privately purchased vaccine in a clearly marked container separate from TVFC vaccine to ensure TVFC vaccine is not inadvertently administered to a non-eligible patient; Make sure to label the formulation pediatric or adult, if applicable; Always store vaccines in their original packaging with lids closed until ready for administration; Never store loose vials or manufacturer-filled syringes outside of their packaging; Diluents should never be frozen; and Arrange vaccines in rows; do not pack a storage unit too tightly. This can restrict air circulation and impact vaccine temperature. New or Repaired Units: Prior to using a new or newly repaired unit to store vaccines, allow 10 business days of refrigerator or freezer temperature readings/recordings (a minimum of two times each workday) on an EC-105 form. Also record the required minimum/maximum temperatures one time at the beginning of each business day to ensure temperatures are within appropriate ranges. Submit the recordings to the Responsible Entity for review and approval,

70 Pg. 68 CHAPTER 3: VACCINE MANAGEMENT before placing vaccine in the storage unit. Minimum and Maximum temperature readings must be reset from the day before at the end each business day (if the device requires this function). Read the refrigerator and freezer instructions carefully before adjusting the temperature control settings and then verify that the temperatures did not change overnight. Some manufacturers recommend resetting the controls in the summer and winter. If so, post instructions on the refrigerator door. Refrigerators and freezers that store TVFC vaccines are to be dedicated to storing vaccine only. Food or drinks in the same refrigerator or freezer as vaccines is not allowed. If other biologics must be stored in the same unit, store them below the vaccines to avoid contamination. Maintaining TVFC temperature logging requirements is mandatory for all TVFC providers: A Temperature Recording Form (EC-105) is required to be located on or near all units that store TVFC vaccines; Freezer and/or refrigerator temperatures are required to be checked, recorded, and initialed twice daily; Minimum and Maximum temperatures must be recorded on the Temperature Recording Form once at the beginning of each business day;

71 Pg. 69 CHAPTER 3: VACCINE MANAGEMENT A TVFC provider using data loggers must still comply with twice daily temperature and Minimum and Maximum recording requirements. Minimum and Maximum temperature readings must be reset from the day before at the end of each business day; Temperatures must be recorded manually on Temperature Recording Forms, even when using a digital data logger; Temperature Recording Forms must be posted on each vaccine storage unit door or nearby in a readily accessible and visible location; and Temperature Recording Forms must be maintained for five years and made easily available. If any out-of-range temperature excursion is observed, the TVFC provider must document all excursions and take the following actions immediately: Place vaccines in a Vaccine Quarantine Bag and label vaccines as DO NOT USE ; Store vaccines in a unit where they can be kept under appropriate conditions; Generate a report from the data logger for manufacturer contact; Contact the vaccine manufacturer, to obtain documentation for the viability of the vaccine; and Contact the Responsible Entity to report the manufacturer s vaccine viability determination and complete the Vaccine Storage Troubleshooting Record attached to the Temperature Recording Form.

72 Pg. 70 CHAPTER 3: VACCINE MANAGEMENT B. Data Logger Requirements As of January 1, 2018, DSHS requires a data logger for all units that contain TVFC or ASN vaccines and a back-up temperature monitoring device (that is also a data logger). Units that store TVFC or ASN vaccines must contain a centrally located data logger with a current and valid Certificate of Calibration Testing (also known as a Report of Calibration), set at a minimum recording interval of at least every 30 minutes. A data logger provides more accurate and comprehensive monitoring of temperature excursions to which vaccines may be exposed. Using a data logger may reduce vaccine loss by providing necessary data when the vaccine would otherwise be lost. A TVFC provider using data loggers must still comply with twice daily temperature and Minimum and Maximum recording requirements. It is recommended that providers download the data from their data loggers at least once per week to ensure that any excursions are identified and addressed in a timely manner. A digital data logger must have: An active temperature display that can be easily read by all staff from the outside of the unit, without having to open the door;

73 Pg. 71 CHAPTER 3: VACCINE MANAGEMENT Functionality that does not require a password to access the temperature display; Alarm for out-of-range temperatures; A display that shows the current temperature, as well as minimum and maximum temperatures; Low battery indicator; Accuracy of +/-1 F (+/-0.5 C); Detachable probe in buffered material; Memory storage of at least 4,000 readings (device will not rewrite over old data and stops recording when memory is full); and User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes. Probes should be placed in buffered material so that they measure temperatures that are more representative of the temperature of the vaccine in the vial rather than the air temperature of the storage unit. Examples of buffers include: A vial filled with liquid (Example: glycol, ethanol, glycerin); A vial filled with loose media (Example: sand, glass beads); or A solid block of material (Example: Teflon, aluminum).

74 Pg. 72 CHAPTER 3: VACCINE MANAGEMENT The TVFC Program does not allow the following temperature monitoring devices: Fluid-filled bio-safe liquid temperature monitoring devices; Bi-metal stem temperature monitoring devices; Food temperature monitoring devices; Household mercury temperature monitoring devices; Chart recorders; Infrared temperature monitoring devices; Temperature monitoring devices that are not calibrated; and Thermometer (beginning in January 2018). These devices can have significant limitations, can be difficult to read, and generally only provide information on the temperature at the precise time they are read. Therefore, temperature fluctuations outside the recommended range may not be detected. The data logger probe must be placed as close to the vaccine as possible. Data logger probes must be: Placed in the main body of the storage unit, away from walls, ceilings, cooling vents, doors, floor, and back of the unit; and Located in a central location of the unit near where the vaccine is stored.

75 Pg. 73 CHAPTER 3: VACCINE MANAGEMENT Note: In pharmaceutical or purpose-built units, the data logger is recommended to be placed in a central location; however, other placements may be suitable because these units maintain more consistent temperatures throughout the unit. The data logger probe must not be: Suspended from wire shelves in the unit; or Suspended by tape attached to the inside ceiling of the unit. Providers enrolled in the TVFC Program are required to have a calibrated data logger in each unit that stores TVFC vaccine that is either International Laboratory Accreditation Cooperation (ILAC) laboratory accredited or has a valid and up-to-date certificate issued by an ILAC laboratory. A valid certificate of calibration matching the serial number of the data logger in use is to be posted on the refrigerator and/or freezer. The certificate is valid for two years from the date of calibration or the date of expiration, whichever occurs first. A continuous-read temperature-recording device does not replace the requirement for a certified data logger. Certificates must contain: Model number; Serial number; Date of calibration; and

76 Pg. 74 CHAPTER 3: VACCINE MANAGEMENT Measurement results that indicates the unit passed the test and the documented uncertainty is within suitable limits (recommended uncertainty is +/-1 F [+/-0.5 C]). A statement indicating that it meets International Organization for Standardization/International Electronic Commission (ISO/IEC) standards. All TVFC providers must have at least one backup data logger with a valid and current certificate of calibration readily available to ensure that temperature assessment and recordings can be performed twice a day. Backup data loggers must be readily available in case a data logger in use is no longer working appropriately or calibration testing of the current equipment is required. The CDC recommends that the backup data logger be stored outside of the storage unit until needed to avoid vaccine space issues and differing temperature readings leading to potential confusion. The backup data logger should have a different calibration retesting date. If both data loggers have the same calibration date, they will need to be sent out for recalibration at the same time. By having different calibration dates, there will always be one data logger available for use.

77 Pg. 75 CHAPTER 3: VACCINE MANAGEMENT Refrigerators and freezers that are manufactured with built-in temperature monitoring capabilities are required to be accompanied by a certificate of calibration for the thermometer, and the thermostat must be capable of being adjusted by the TVFC provider as needed to maintain proper temperature. These units must meet all TVFC data logger requirements. In addition, TVFC providers are required have a room thermometer to record the room temperature when a temperature excursion occurs in a vaccine storage unit. This is important for making vaccine viability determinations, if necessary. Figure 3-1, on the next page, presents an example of a valid certificate of calibration.

78 Pg. 76 CHAPTER 3: VACCINE MANAGEMENT Figure 3-1: Example of a Valid Certified Data Logger Certificate

79 Pg. 77 CHAPTER 3: VACCINE MANAGEMENT All TVFC vaccines must be stored separately from privately purchased vaccines and must be labeled accordingly. C. Vaccine Storage Requirements Some vaccines are sensitive to light and their efficacy could be compromised if exposed to the light. All TVFC providers must safeguard the following vaccines from light: Hib, HPV, MCV4, MMR, MMRV, Rotavirus, and Varicella. All of these vaccines, with the exception of Varicella and MMRV, are to be stored in the refrigerator and must never be frozen. Varicella and MMRV must be stored in the freezer in a continuously frozen state <5 F (-15 C). Measles, Mumps, and Rubella (MMR) vaccine may be stored in either a refrigerator or freezer. All vaccines must be stored in the central area of the refrigerator and/or freezer shelves, not in the vegetable bins, meat drawers, in the door, or on the floor. Storing vaccines in the central body of the refrigerator and/or freezer helps maintain proper temperatures for the vaccines. Vaccines must be stored and/or stacked to allow cold air to circulate freely. All TVFC vaccines must be stored separately from privately purchased vaccines and must be labeled accordingly. All TVFC providers also enrolled in the ASN Program must separate TVFC provided pediatric doses from ASN supplied adult doses. All TVFC providers must identify sufficient alternate

80 Pg. 78 CHAPTER 3: VACCINE MANAGEMENT During reenrollment, the primary and back-up vaccine coordinators must complete the mandatory 2018 TVFC Provider Policy Training module. space to store vaccines and maintain the cold chain during any period when the refrigerator/freezer is out of service. D. Protective Equipment The power supply for vaccine storage units must be protected by following: Plug unit directly into a wall outlet; Plug only one unit into an outlet; Plug guards are required to be used on all units that store TVFC vaccines. Plug guards are effective tools in preventing the accidental unplugging of equipment; A Do Not Unplug sign is required to be posted on or near all outlets of units; and A Do Not Disconnect sign must be posted by each circuit breaker. Do not: Use multi-outlet power strips; Use outlets with built in circuit switchers; Use power outlets that can be activated by a wall switch; E. Personnel Vaccine viability depends on the knowledge and habits of the clinic staff. All staff who handle TVFC vaccine must be trained on proper storage, handling, and administration of vaccine as well as aware of and familiar with the written procedures for

81 Pg. 79 CHAPTER 3: VACCINE MANAGEMENT emergency situations to assure continued viability of the vaccines. The site is required to designate a primary and at least one back-up vaccine coordinator to ensure that the TVFC vaccines are handled and stored properly. The training requirements for vaccine coordinators are as follows: All new TVFC providers must have their primary and back-up vaccine coordinators complete the mandatory 2018 TVFC Provider Policy Training module and CDC You Call the Shots training modules and provide the Certificates of Completion to their Responsible Entity. Replacement primary and/or back-up vaccine coordinators must complete the mandatory 2018 TVFC Provider Policy Training module and CDC You Call the Shots training modules and provide the Certificates of Completion to their Responsible Entity. During re-enrollment, the primary and back-up vaccine coordinators must complete the mandatory 2018 TVFC Provider Policy Training module and upload the Certificate of Completion into the electronic re-enrollment form. The Immunization Unit has developed Texas Vaccine Education Online (VEO) modules to provide short online training courses on topics related to vaccines. Individuals may log in and take any course free of charge. Additional information and a course listing are available at

82 Pg. 80 CHAPTER 3: VACCINE MANAGEMENT F. Mass Vaccination Clinic Requirements To ensure vaccine storage and handling for mass vaccination clinics is managed properly the following storage and handling practices are required: All TVFC vaccine must be ordered and shipped directly to a location within the ordering provider s DSHS Health Service Region (HSR). The vaccine must be properly transported, not shipped, to local schools or other community sites where the mass vaccination clinics will be held. Only amounts of vaccines that are appropriate, based on TVFC need, should be transported to each scheduled clinic. Vaccine must be transported to and from the scheduled mass vaccination clinic at appropriate temperatures and must be monitored by a continuous monitoring and recording device that includes a digital display (that can be viewed outside of the storage unit) and probe in buffered material that closely resembles a vaccine. The vaccine being transported should be tracked in order to maintain accountability for monthly reporting in EVI. This includes: Vaccine type(s) and brand names; Quantity of each type; NDC numbers; Lot numbers; and Expiration dates.

83 Pg. 81 CHAPTER 3: VACCINE MANAGEMENT Upon arrival at the clinic site, the TVFC mass vaccination provider must ensure that the vaccine is stored to maintain the appropriate temperature throughout the clinic day. Since the vaccine is at a temporary location, temperature data must be reviewed and documented every hour during the day of the clinic using a continuous monitoring and recording device with a digital display and probe in buffered material. Temperature form EC-105 may be used to document hourly temperatures. After each clinic day, the TVFC provider must perform a physical count of the remaining vaccine and assess temperatures prior to placing vaccine back into storage units to prevent inadvertent administration of vaccine that may have been compromised. Vaccines exposed to temperature excursions, when the temperature goes above or below its required temperature, must be separated in a Vaccine Quarantine Bag and labeled Do Not Use until further information can be gathered from the manufacturer(s). The vaccine should be kept at appropriate temperatures until the viability determination is made. G. Routine and Emergency Storage and Handling Plan All TVFC providers must have plans for routine and emergency vaccine management. The TVFC Program provides templates

84 Pg. 82 CHAPTER 3: VACCINE MANAGEMENT for the Vaccine Management Plan and the Emergency Vaccine Storage and Handling Plan Checklist. The plan and checklist templates contain comprehensive information on best practices and the most current information about the storage and handling of vaccines. A TVFC provider is not required to use these templates, but they are valuable tools available to providers should they need assistance in developing an emergency plan. If the templates are not used, the TVFC provider must develop routine and emergency vaccine management plans that include all of the information on the templates provided by the TVFC Program. The Vaccine Management Plan and the Emergency Vaccine Storage and Handling Plan Checklist must be reviewed and updated annually. They must include the signature, name, and title of the preparer as well as the date the documents were reviewed. The following items must be addressed in the Emergency Vaccine Storage and Handling Plan: 1.1 Identify a responsible primary person and a responsible back-up person to carry out the contingency plan. Be sure to include contact information such as home, office, and cell phone numbers for both persons. Contact information must be updated annually and when changes occur.

85 Pg. 83 CHAPTER 3: VACCINE MANAGEMENT 1.2 Identify an alternative location to take the TVFC vaccine for storage. A location with a power generator or other alternate source of power such as a hospital, pharmacy, or grocery store is preferable. Ideally, this facility must be located within a reasonable distance from the TVFC provider s clinic, and can maintain the cold chain during any period when the TVFC provider s refrigerator or freezer is out of service, as well as adequate space to accommodate the largest vaccine inventory. Temperatures for storage units are required to be monitored and recorded. 1.3 Adequate supplies in amounts sufficient for packing and transporting the entire TVFC vaccine inventory must be available in case of an emergency. 1.4 Be sure to contact the emergency storage location for their approval before including them as part of the plan. List their contact person(s) and phone number(s) on the plan. An alternative back-up location must be considered in case the primary alternative location is unavailable or unable to store the vaccine inventory for any reason. All TVFC providers will be asked to provide a copy of their Vaccine Management Plan and Emergency Vaccine Storage and Handling Plan Checklist at TVFC Compliance Site Visits. The documents must be posted on or near the refrigerator or

86 Pg. 84 CHAPTER 3: VACCINE MANAGEMENT freezer containing the TVFC vaccine. The TVFC provider must ensure all employees involved with vaccine management are aware of this plan. H. Vaccine Protection in the Event of an Emergency As noted above, every facility maintaining an inventory of state-provided vaccine is required to develop and display an Emergency Vaccine Storage and Handling Plan in the event of emergencies that could result in the loss of vaccine. Once completed, this template can serve as the required Emergency Vaccine Storage and Handling Plan. All TVFC providers must review and update this plan annually or more frequently if there are any changes to the plan or changes in staff responsible for vaccine management, storage, and handling. The most current Emergency Vaccine Storage and Handling Plan will be reviewed during TVFC Compliance Site Visits and any Unannounced Storage and Handling Visits. In the event of an emergency, a TVFC provider must contact their Responsible Entity immediately to inform them of the situation.

87 Pg. 85 CHAPTER 3: VACCINE MANAGEMENT The TVFC provider will need to be prepared to provide the following information: The temperature of the vaccine; The amount of vaccine; Expiration dates of the vaccine; and How long the vaccine was exposed to inappropriate temperatures. The TVFC provider will need to specify the following steps when transporting vaccine to the alternate location: Document the time of the emergency situation/power outage; Document the temperature of the refrigerator and freezer before removing any vaccine for transportation; Indicate which containers are being used and how the refrigerated vaccine will be packed for transportation (e.g., conditioned water bottles separated from the vaccine by layered packing materials to prevent freezing and damage); If frozen vaccine is being transported, indicate whether a portable freezer or cooler will be used and what packing materials will be used; Take inventory of the vaccine as it is moved into the transport container, being careful to indicate the number of doses of each vaccine and the expiration dates. Use the Vaccine Transfer Authorization Form; and Ensure the Emergency Vaccine Storage and Handling Plan Checklist is available for documenting this process.

88 Pg. 86 CHAPTER 3: VACCINE MANAGEMENT I. Cold Chain Management and Vaccine Transport The TVFC Program requires vaccines to be stored properly from the time they are manufactured until the time they are administered. The system used to maintain and distribute vaccines in optimal condition is called the cold chain. All TVFC providers must identify sufficient alternative space to store TVFC vaccines and maintain the cold chain during any period when the refrigerator or freezer is out of service. Providers must ensure adequate supplies for packing and transporting the entire TVFC provider s vaccine supply/inventory must be available in case of an emergency. Avoid prolonged temperature extremes inside vehicles, by using transport containers containing the vaccines and taking the quickest route possible. Do not leave vaccines unattended in vehicles. Do not place vaccines in the trunk of a vehicle. Pack refrigerated vaccines first. If followed, the directions below will help maintain the cold chain for up to eight hours during transport of refrigerated and frozen vaccines. Refrigerated Vaccine Transport Assemble Packing Supplies CDC recommends transport with a portable refrigerator unit. If this type of unit is not available, a hard-sided insulated cooler

89 Pg. 87 CHAPTER 3: VACCINE MANAGEMENT with at least 2-inch walls, Styrofoam vaccine shipping container or other qualified container may be used if it can maintain the recommended temperature range (between 36 F [2 C] and 46 F [8 C]). Hard-sided cooler, Styrofoam vaccine shipping container, or other qualified container is required: Coolers should be large enough to hold the TVFC provider s typical supply of refrigerated vaccines; Original shipping boxes from the manufacturer can be used, if available; and Do NOT use soft-sided collapsible coolers. Label the container with facility name and Fragile Vaccines Do Not Freeze and the date and time the vaccine was removed from the permanent storage unit. Conditioned frozen water bottles are required: Use 16.9 oz. bottles for medium/large coolers and 8 oz. bottles for small coolers; Before use, condition the frozen water bottles. This is done by placing them in a sink filled with several inches of cool or lukewarm water until there is a layer of water forming near the inner surface of the bottle. The bottle is properly conditioned when the ice block spins freely within the bottle when rotated; and DO NOT reuse coolant packs from original vaccine shipping containers, they may freeze vaccine.

90 Pg. 88 CHAPTER 3: VACCINE MANAGEMENT Insulating material two of each layer is needed: Insulating cushioning material Bubble wrap, packing foam, or Styrofoam for a layer, at least 1-inch thick, above and below the vaccines. Make sure it covers the cardboard completely; Corrugated cardboard two pieces cut to fit the internal dimensions of the cooler(s) and placed between the insulating cushioning material and the conditioned water bottles; and DO NOT use packing peanuts or other lose material that may shift during transport. Temperature monitoring device A digital data logger with a buffered probe should be used: The probe is buffered by pre-chilling it in the refrigerator for at least five hours prior to transport; Data logger must have current and valid certificate of calibration testing; Data logger must be accurate within +/- 1 F (+/- 0.5 C); and The temperature monitoring device currently stored in the refrigerator can be used for transport, as long as there is a device in place to measure the temperature for remaining vaccines.

91 Pg. 89 CHAPTER 3: VACCINE MANAGEMENT Packing for Transport Line the bottom of the cooler with a single layer of conditioned water bottles; Place a sheet of corrugated cardboard over the water bottles; Place at least 2 layer of insulating material (i.e., bubblewrap, packing foam, or Styrofoam) over the cardboard; Stack boxes of vaccines and diluents on top of insulating material; When cooler is halfway full, place the buffered temperature probe in the center of the vaccines, but keep the display out of the cooler; Cover vaccines with another 2 layer of insulating material; Add the second layer of corrugated cardboard; Fill the remaining space in the cooler with conditioned water bottles; Close the lid of the cooler securely and attach the digital data logger display and a temperature log to the top of the lid to record and monitor the temperature during transport; Use the Temperature Recording Form to record the time and temperature inside of the storage unit at the time the vaccines are removed; If vaccines are kept in a transport container for longer than an hour, record the temperatures hourly; and As soon as the destination site is reached, check and record the vaccine temperature.

92 Pg. 90 CHAPTER 3: VACCINE MANAGEMENT In an emergency, if the vaccine temperature is between 36 F [2 C] and 46 F [8 C], place the vaccine in the refrigerator. If the vaccine is below 36 F or above 46 F, place the vaccine in a quarantine bag in the refrigerator and immediately contact the vaccine manufacturer to determine viability. Next, contact the Responsible Entity with the manufacturer s viability determination. Note: Always keep vaccine properly stored until otherwise instructed by the vaccine manufacturer or the TVFC Program. Frozen Vaccine Transport Varicella and MMRV vaccines are fragile and must be frozen! The CDC and the vaccine manufacturer do not recommend transporting varicella or MMRV. If these vaccines need to be relocated in an emergency situation, the following steps must be taken. Assemble Packing Supplies: Portable Freezer The CDC recommends transport with a portable freezer unit that maintains the temperature between -58 F and +5 F (-50 C and -15 C). Portable freezers may be available for rent. Label the portable freezer with the facility name and Fragile Vaccines Keep Frozen and the date and time the vaccine was removed from the permanent storage unit.

93 Pg. 91 CHAPTER 3: VACCINE MANAGEMENT In addition to the above packing instructions: Ensure that the water bottles used in the cooler are frozen; Place a calibrated data logger in the container used for transport as close as possible to the vaccine; Use a Temperature Recording Form to record the time and temperature inside of the storage unit at the time the vaccines are removed. Also, record the temperature of the transport container on the Temperature Recording Form hourly; Immediately upon arrival at the destination, place vaccines in a freezer at a temperature range between -58 F and +5 F (-50 C and -15 C). Any stand-alone freezer that maintains these temperatures is acceptable; Document the time the vaccine was removed from the transport container and placed in the alternate storage unit. Also, document the temperature of the vaccine when it was removed from the transport container and placed in the alternate storage unit; Immediately contact the vaccine manufacturer for viability data and guidance any time frozen vaccine has been exposed to a temperature above +5 F [-15 C]. Do not discard the vaccine without contacting the manufacturer. Viability determination will be made on a case-by-case basis; and Contact the Responsible Entity with the viability determination from the manufacturer.

94 Pg. 92 CHAPTER 3: VACCINE MANAGEMENT Figures 3-2 and 3-3 on the following pages, illustrate proper vaccine storage and handling for transport during emergencies when portable refrigerators and/or freezers are not available.

95 Pg. 93 CHAPTER 3: VACCINE MANAGEMENT Figure 3-2: Supplies for Transport of Vaccines during Emergencies

96 Pg. 94 CHAPTER 3: VACCINE MANAGEMENT Figure 3-3: Packing of Vaccine for Transport during Emergencies